Question 1

What types of dental devices does Ho Dental Co., Inc. manufacture?

Accepted Answer

Ho Dental Co., Inc. specializes in dental impression materials, including silicone-based vinyl polysiloxane (VPS) products like light and heavy body cartridges and syringes. Their portfolio also covers disposable dual-arch impression trays, dental floss, gingival retraction cords, facebow devices, and automated mixing systems for dental materials, such as VPS mixers and mixing nozzles. These products are designed for precise dental impressions and material application in clinical settings.

Question 2

Where is Ho Dental Co., Inc. based, and what market do they serve?

Accepted Answer

Ho Dental Co., Inc. is based in the United States. Their devices are intended for the US market and are developed to meet regulatory requirements for dental devices, ensuring compliance with safety and performance standards for clinical use.

Question 3

Which regulatory registries list Ho Dental Co., Inc.’s devices?

Accepted Answer

Ho Dental Co., Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. Many of their products are also authorised through the FDA’s 510(k) pathway, which is a premarket submission required for Class II devices to demonstrate substantial equivalence to a legally marketed predicate device.

Question 4

How are Ho Dental Co., Inc.’s devices classified under FDA regulations?

Accepted Answer

Ho Dental Co., Inc.’s devices fall under FDA Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway, such as the 510(k) submission for Class II devices.

Device	Model / Reference	Registries	Class	Status
Vaccu-sil VPS Light Body Cartridge	Regular Set	FDA UDI	Class II	Active
Vaccu-sil VPS Heavy Body 120 Impression Material	Fast Set	FDA UDI	Class II	Active
Harmony Posterior Disposable Dual Arch Try	Posterior	FDA UDI	Class I	Active
Vaccu-sil VPS Heavy Body 50 Impression Material	Fast Set	FDA UDI	Class II	Active
VacuCord Gingival Retraction Cord	Size 1	FDA UDI	Class I	Active
Vaccu-sil VPS Heavy Body 50 Impression Material	Regular Set	FDA UDI	Class II	Active
Vaccu-Sil Mojo Complete Light Body Syringe	Regular Set	FDA UDI	Class II	Active
Vaccu-sil VPS Heavy Body 120 Impression Material	Regular Set	FDA UDI	Class II	Active
Vaccu-sil Bite Registration	Regular Set	FDA UDI	Class II	Active
Vacu-Mixer Automated VPS Mixing Machine	Vacu-Mixer	FDA UDI	Class I	Active
Dynamic Mixing Tips	Vacu-Mixer Tip	FDA UDI	Class I	Active
Vaccu-Sil Mojo Complete Light Body Syringe	Fast Set	FDA UDI	Class II	Active
VacuCord Gingival Retraction Cord	Size 2	FDA UDI	Class I	Active
Mojo VPS Light Body Impression Syringe	Empty	FDA UDI	Class I	Active
VacCord Gingival Retraction Cord	Size 0	FDA UDI	Class I	Active
Harmony Anterior Disposable Dual Arch Tray	Anterior	FDA UDI	Class I	Active
VacuCord Gingival Retraction Cord	Size 00	FDA UDI	Class I	Active
Vaccu-sil VPS Light Body Cartridge	Fast Set	FDA UDI	Class II	Active
Facial Plane Relator	FPR-102	FDA UDI	Class I	Active
Hd-4 Crown & Bridge Alloy	K905034	FDA 510(k)	Class II	Active

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